In addition to acquiring the appropriate Manufacturer's Evidence prior to making an application, sponsors should also consider having their manufacturer provide them with a Declaration of Conformity in support of their medical device, or IVD medical device. The TGA may request this documentation at any time.
For information on the documentation you may need for the inclusion process and to maintain your ARTG inclusion, go to Supporting documentation for inclusion of a medical device.
Does your device require conformity assessment? Read the information on conformity assessment and overseas market authorisation prior to application, to ensure you submit the device under the right classification with the right conformity assessment documentation.
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PageLearn how to submit a variation to Manufacturer Evidence
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GuidanceGuidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).